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Steroid Eye Drops in Chronic Central Serous Chorioretinopathy

Sponsored by Radboud University Medical Center

About this trial

Last updated a year ago

Study ID

112907

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

In this pilot study the effect and safety of the use of steroid eye drops in chronic central serous chorioretinopathy (cCSC) will be evaluated. The study is conducted as a randomized single-blind placebo-controlled trial. Forty patients will be randomized to either steroid eye drops or placebo eye drops. Patients will self-administer the eye drops three times a day for four weeks.

What are the participation requirements?

Yes

Inclusion Criteria

- Male and female patients aged 18 years or older

- Subretinal and/or intraretinal fluid on OCT and subjective visual loss or presence of Subretinal and/or intraretinal fluid for 3 months or longer

- Patient is able to self-administer eye drops

- Complex or Severe Chronic Central Serous Chorioretinopathy, with at least one of the following clinical findings that are present within the vascular arcades: Cumulative areas (>2 optic disc diameters) of diffuse atrophic RPE alterations visualized on mid-phase FA or on FAF; Multifocal "hot spots": at least 2 "hot spots" of leakage separated by at least 1 disc diameter of nonhyperfluorescent healthy-appearing retina on mid-phase FA; Diffuse leakage: an area of diffuse fluorescein leakage >1 optic disc diameter on mid-phase FA, without an evident leaking focus; Presence of posterior cystoid retinal degeneration assessed on OCT.

No

Exclusion Criteria

- Evidence of other retinal diagnoses: ((History of) exudative age-related macular degeneration, Suspicion of secondary choroidal neovascularization, Polypoidal choroidal vasculopathy, Multifocal choroiditis, Retinal vascular occlusions, Pseudoxanthoma elasticum, Amblyopia, Severe myopia (more than -6 diopters).

- Current treatment with corticosteroids or corticosteroid use within 3 months before the baseline visit

- Treatment with PDT, subthreshold micropulse laser or focal laser photocoagulation 6 months prior to the baseline visit.

- Treatment with anti-vascular endothelial growth factor (anti-VEGF), MR-antagonists or carbonic anhydrase inhibitors within 6 weeks prior to the baseline visit. If patients were treated with anti-VEGF, MR-antagonists or carbonic anhydrase inhibitors 3 months to 6 weeks prior to the baseline, patients will only be included if there was no sufficient response to treatment.

- Pregnant or breastfeeding women

- Allergy to topical ophthalmic steroids.

- Media opacities that prohibit detailed multimodal imaging

- (BCVA <20/200) (Snellen equivalent)

- Contraindications for fluorescein angiography or ICG angiography (known allergies especially against shellfish, previous reactions)

Locations

Location

Status

Recruiting
Not yet recruiting